Senti is a medical device startup working to create innovative healthcare solutions and do so ethically. This presents significant challenges. In this piece, founder Phil Alton shares his ideas for working with other like-minded startup businesses, to develop a network of organisations able to exert influence on a global supply chain in the cause of protecting human dignity.
If you’re anything like us – working to positively impact a particular group of people; passionate about the products you’re creating; striving to develop a business which will create real value – then you’ve probably spent a bit of time thinking about whether you’re doing the right things in the right way.
And, if you’re even more like us – creating hardware or textile products, or medical devices – then you’ve probably realised by now that these questions are fraught with challenges.
As a small team, we’re often wearing multiple hats. Beyond the typical concerns of a startup (achieving product-market fit), the Senti team have worked on creating light-touch processes for approving suppliers, purchasing items, and verifying incoming materials. We’ve wrestled with how to maintain high quality and ISO 13485-compliance (the standard for medical device quality management – see image above), particularly in regard to suppliers and purchases, whilst retaining the agility of a startup … and without having a team member working full time on procurement and inventory.
We have made considerable progress, creating a set of processes which work really well to balance quality considerations against agility – all in the context of the risk that our supply and purchasing processes pose to the safety of the products we create. We’ve developed an all-singing, all-dancing google spreadsheet (fully validated to meet the requirements of ISO 13485) to support these processes. It enables compliant purchasing and generates appropriate records that demonstrate both the effectiveness of and our conformity to these processes.
In short, as far as supply chain management and purchasing is concerned, we’re ready for ISO 13485 certification, with fit-for-purpose procedures and tools that have minimal detrimental impact on our agility or time.
However, we’re passionate not just about maintaining high quality, but also about good ethics within our supply chain … and, with a product that includes both electronic components and textiles (the most difficult-to-source-ethically products in the world), this is proving to be an even greater challenge. The recent UK Health and Care bill is now set to provide a legal framework for these good ethical practices and eradicate modern slavery from the NHS Supply Chain. This laudable legisalation makes these questions unignorable for medical device manufacturers.
We’ve realised that we cannot solve this problem alone – having neither the time, the means, nor the power to hold our suppliers accountable. Outside of a tick-box on our supplier surveys, we are blind to our suppliers’ practices. Our suppliers’ suppliers are entirely invisible to us. But we are not content to leave this monumentally important challenge to larger companies or governments: over the last decades they have often failed to enforce ethical supply chains and hold suppliers accountable for poor quality or unsafe products, environmental abuses, abuse of workers, slave labour, or even, worst of all, complicity in genocide.
Historically, these challenges have been overcome through substantial consumer and citizen action – forcing the hands of corporations and governments to change practices and strengthen protections of human dignity. Globalisation disempowers citizens by placing them several steps removed from our fellow humans who toil to create the products we use every day. No longer can we individually choose to boycott sugar from the plantations: cotton from Xinjiang is more insidious, transmuted as it passes through an opaque network of manufacturers, assemblers, resellers, and distributors as it moves from the fields into our clothing. If you ask yourself whether your clothes have been created through slave labour, you may find yourself more uncertain than ever.
While a remedy for this intolerable situation remains unforthcoming, the duty to speak up and demand ethical action falls elsewhere. Communities lack the scale to act globally: but are there other actors with that ability? Citizens, so to speak, of the global economy, who could promote change on a global scale? Acting alone, a single small business or startup’s impact is insignificant. But what if our voice were added to a multitude of small businesses, startups, and scaleups? What if this network, all sharing supplier intelligence and acting together, demanded redress where human dignity has been violated?
This is our vision for startup ethically: a network of small businesses, startups, and scaleups able to influence the global stage in the cause of protecting human dignity. Alone, we may not have the time, means, or power to sustain accountable supply chains – but, as a network, we can create enough leverage to demand better.
In Part 2, I describe how we may implement this network.